Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.

Inclusion criteria

• Subject is in good health (as determined by medical history)
• Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
• Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only)

Exclusion criteria

• Subject has hypersensitivity or allergy to rifaximin or rifampin
• Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
• Subject participated in an investigational drug or device study within the 30 days prior to enrollment
• Subject received rifaximin in a previous clinical study
• Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
• Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug